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estrogens conjugated synthetic (Rx)Brand and Other Names:Cenestin, Enjuvia

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 0.3mg
  • 0.45mg
  • 0.625mg
  • 0.9mg
  • 1.25mg
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Menopausal Vasomotor Symptoms

0.45-1.25 mg PO qDay

Atrophic Vaginits, Kraurosis Vulvae, Perimenopausal Dyspareunia

PO: 0.3 mg qDay

Safety & efficacy not established

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Interactions

Interaction Checker

estrogens conjugated synthetic and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Abdominal pain

            Back pain

            Bloating

            Breast enlargement

            Breast tenderness

            Headache

            Nausea

            Peripheral edema

            Vomiting

            Frequency Not Defined

            Amenorrhea

            Breakthrough bleeding

            Corneal curvation change

            Depression

            Diarrhea

            Melasma

            Spotting

            Weight changes

            Postmarketing reports

            Abdominal discomfort, abdominal distension

            Muscle spasms

            Dizziness

            Insomnia

            Breast pain

            Alopecia

            Rash

            Urticaria

            Deep vein thrombosis, thrombosis

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            Warnings

            Black Box Warnings

            Estrogens increase risk of endometrial cancer

            • Close clinical surveillance of all women taking estrogens is important
            • Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding
            • There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses

            Cardiovascular risks

            • Estrogens with and without progestins should not be used to prevent cardiovascular disease
            • Estrogens plus progestins: Women’s Health Initiative (WHI) Estrogen Plus Progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, & deep vein thrombosis (DVT) in postmenopausal women (aged 50-79 yr) during 5.6 yr of treatment w/ daily PO conjugated estrogens (CE 0.625 mg) combined w/ medroxyprogesterone acetate (MPA 2.5 mg) compared with placebo
            • Estrogens alone: A substudy of the WHI Study reported increased risk for stroke and DVT in postmenopausal women (aged 50-79 yr) during 6.8 year of treatment with oral conjugated estrogens (0.625 mg/day) alone compared with placebo

            Dementia risks

            • Estrogens with and without progestins should not be used to prevent dementia
            • Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women aged 65 years or older during 4 year of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, compared with placebo
            • Estrogens alone: A substudy of the WHIMS reported an increased risk of developing probable dementia in postmenopausal women aged 65 years or older during 5.2 years of treatment with conjugated estrogens 0.625 mg alone compared w/ placebo
            • Unknown whether these findings apply to younger postmenopausal women

            Dose & duration

            • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins
            • Because of these risks, estrogens with or without progestins should be prescribed at lowest effective dose and for shortest duration consistent with treatment goals and individual risks

            Contraindications

            Documented hypersensitivity; active or history of breast cancer, arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

            Uncontrolled hypertension, diabetes mellitus with vascular involvement

            Jaundice with prior oral contraceptive use

            History of migraine with aura

            Estrogen-dependent neoplasia

            Undiagnosed abnormal vaginal bleeding

            Liver disease, liver tumors

            Known or suspected pregnancy

            Cautions

            Caution in history of hyperlipidemias, HTN, hepatic/renal impairment, uterine leiomyomata, porphyria, patients with defects of lipoprotein metabolism, hypertriglyceridemia, ovarian cancer, SLE, and the elderly

            Discontinue if the following develop jaundice, any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

            Discontinue 4 week before major surgery or prolonged immobilization

            Use caution in patients with asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas; exacerbations may occur

            Increased risk of ovarian and endometrial cancer

            Long-term postmenopausal estrogen treatment has been associated with increased risk of MI, stroke, DVT/PE, and dementia

            Patients on warfarin/oral anticoagulants: Estrogens increase thromboembolic risk; increase in anticoagulant dose may be warranted

            Not approved for osteoporosis prevention

            Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema

            Estrogens increase the risk of gallbladder disease

            Estrogen administration reported to lead to severe hypercalcemia in women with breast cancer and bone metastases; if hypercalcemia occurs, discontinue use and take appropriate measures to reduce serum calcium level

            Retinal vascular thrombosis may occur; discontinue therapy, if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine, pending visual examination; permanently discontinue if examination reveals papilledema or renal vascular lesions

            Consider discontinuation of therapy if pancreatitis occurs; in women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis

            Monitor thyroid function in order to maintain free thyroid hormone levels in an acceptable range

            Use with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur

            A few cases of malignant transformation of residual endometrial implants reported in women treated post-hysterectomy with estrogen-alone therapy; consider addition of progestin in women known to have residual endometriosis post-hysterectomy

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: Controversial; estrogens are excreted into breast milk in small quantities, use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Replaces natural estrogen. Important for development and maintenance of the female reproductive system and secondary sexual characteristics.

            Derived from plant sources; B but not A contains delta 8,9-dehydroestrone sulfate

            Pharmacokinetics

            Onset: 2-4 wk (menopause; PO)

            Peak plasma time: 8 hr (PO)

            Bioavailability: Readily absorbed from GI tract

            Protein Bound: 80%

            Metabolism: In liver to inactive sulfates and glucuronides which are then excreted in urine and bile

            Metabolites: Estradiol, estrone, estriol

            Excretion: Mainly in urine as conjugates with small amount of unchanged drug, most estrogens are also excreted in bile and undergo enterohepatic recycling

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
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            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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